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Accelerating the drug regulatory process through a federated cloud ecosystem

Cloud-based regulatory platforms are transitioning from pilots to practical solutions. Sustainable adoption now relies on global coordination, continued trust and a shift towards federated, interoperable models.
By
  1. Andrew S. Robertson

    1. Takeda Pharmaceuticals, Cambridge, MA, USA.

  2. Nahid Latif

    1. Takeda Pharmaceuticals, Cambridge, MA, USA.

  3. Raymond C. Votzmeyer

    1. AbbVie, North Chicago, IL, USA.

  4. Natalie Tolli

    1. AbbVie, North Chicago, IL, USA.

  5. Mark Taisey

    1. Amgen, Thousand Oaks, CA, USA.

  6. Kevin Bugin

    1. Amgen, Thousand Oaks, CA, USA.

  7. Kathy Williams

    1. AstraZeneca, Gaithersburg, MD, USA.

  8. Michael Garvin

    1. AstraZeneca, Gaithersburg, MD, USA.

  9. Max Wegner

    1. Bayer Pharmaceuticals, Wuppertal, Germany.

  10. Antoine Manson

    1. Bayer Pharmaceuticals, Wuppertal, Germany.

  11. Jennifer Dudinak

    1. Bristol Myers Squibb, Madison, NJ, USA.

  12. Sandra Krogulski

    1. Bristol Myers Squibb, Madison, NJ, USA.

  13. Carlos O. Garner

    1. Eli Lilly and Company, Indianapolis, IN, USA.

  14. Jeffrey Francer

    1. Eli Lilly and Company, Indianapolis, IN, USA.

  15. Sabine Luik

    1. GlaxoSmithKline, Ware, UK.

  16. Jerry Stewart

    1. GlaxoSmithKline, Ware, UK.

  17. Katrin Rupalla

    1. Johnson & Johnson, Titusville, NJ, USA.

  18. Ginny Beakes-Read

    1. Johnson & Johnson, Titusville, NJ, USA.

  19. Sean P. Curtis

    1. Merck & Co., Rahway, NJ, USA.

  20. Jayne Ware

    1. Merck & Co., Rahway, NJ, USA.

  21. Kevin Carl

    1. Novartis Pharmaceuticals, East Hanover, NJ, USA.

  22. Nicole Mahoney

    1. Novartis Pharmaceuticals, East Hanover, NJ, USA.

  23. Donna Boyce

    1. Pfizer, New York, NY, USA.

  24. David C. Isom

    1. Pfizer, New York, NY, USA.

  25. Michelle Rohrer

    1. Roche/Genentech, South San Francisco, California, USA.

  26. Fabio Bisordi

    1. Roche/Genentech, South San Francisco, California, USA.

  27. Peggy Lipp

    1. Sanofi, Paris, France.

  28. Lina Aljuburi

    1. Sanofi, Paris, France.

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doi: https://doi.org/10.1038/d41573-026-00014-8

References

  1. Robertson, A. S. et al. Cloud-based data systems in drug regulation: an industry perspective. Nat. Rev. Drug Discov. 19, 365–366 (2020).

    Article  PubMed  Google Scholar 

  2. Grossman, R. L. et al. A framework for the interoperability of cloud platforms: towards FAIR Data in SAFE environments. Sci. Data 11, 241 (2024).

    Article  PubMed  Google Scholar 

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Competing Interests

The authors declare no competing interests.

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